Senior Manager, Global Regulatory Operations, Publisher

Remote from: Denmark
Annual salary: Undisclosed
Salary information is not provided for this position. Check our Salary Directory to estimate the average compensation for similar roles.
Department: Legal & Compliance
Employment type: Full Time,
Job posted: 8 Jun 2026
Apply before: 8 Jul 2026
Experience level: Senior
Views / Applies: 15 / 5

Engineering a transformative tomorrow

Biotechnology
1999

AI Summary

Genmab is seeking a Senior Manager for Global Regulatory Operations to lead the creation, assembly, and publishing of electronic submissions (eCTD, NeeS) for FDA, EMA, and other health authorities. This role requires deep expertise in regulatory publishing standards, lifecycle management, and quality control. The ideal candidate will have 8+ years of pharma experience, strong knowledge of IND/BLA/MAA requirements, and proficiency with Adobe Acrobat and MS Office. The position offers an opportunity to drive innovation in regulatory processes while collaborating with cross-functional teams. It is best suited for a self-starter with excellent communication skills and attention to detail.

Role DNA

Job Complexity

Easy Hard

Pace & Pressure

Relaxed Fast-paced

Autonomy Level

Guided Full Ownership

Communication Load

Independent Highly Collaborative

AI Insight The role requires extensive regulatory knowledge, management of complex submissions, and balancing multiple priorities, making it challenging but not the hardest due to established frameworks.

Salary Analysis

AI Insight No salary was provided in the listing. Based on market data for a Senior Manager in Regulatory Operations in the biotech/pharma industry, the typical US median salary is around $150,000. The offered compensation is expected to be competitive, given the seniority and specialized skills required.

Key Skills

Regulatory Operations eCTD Publishing Compliance Pharma Submissions FDA EMA Document Management Adobe Acrobat

Cover Letter Sample

Dear Hiring Manager,

I am writing to express my strong interest in the Senior Manager, Global Regulatory Operations, Publisher position at Genmab. With over 8 years of experience in regulatory operations and a deep understanding of electronic submission standards (eCTD, NeeS), I am confident in my ability to lead the publishing and submission management for global health authorities.

In my previous role, I successfully managed the end-to-end submission of multiple BLAs and INDs, ensuring compliance with FDA, EMA, and other regulatory bodies. My technical proficiency with publishing systems and Adobe Acrobat, combined with my attention to detail, has consistently resulted in error-free submissions.

I am particularly drawn to Genmab's commitment to innovation and its purpose-driven culture. I thrive in fast-paced environments and enjoy collaborating with cross-functional teams to drive timelines and deliverables. I am eager to bring my expertise to support Genmab's groundbreaking antibody therapies.

Thank you for considering my application. I look forward to discussing how I can contribute to your team.

Sincerely,
[Your Name]

Possible Interview Questions

Can you describe your experience with eCTD and NeeS submissions for different health authorities?

I have over 8 years of experience preparing eCTD and NeeS submissions for FDA, EMA, MHRA, and SwissMedic. I am proficient in lifecycle management, including initial submissions, amendments, and responses to health authority questions. I ensure compliance with each agency's specific requirements and have a track record of timely, error-free submissions.

How do you ensure quality control in regulatory submissions?

I perform thorough QC and technical validation using tools like validation software and checklists. I review document formatting, hyperlinks, bookmarks, and metadata to align with internal and external standards. I also collaborate with authors to resolve any issues before final approval.

Describe a time when you had to manage multiple submissions with tight deadlines. How did you prioritize?

In a previous role, I managed simultaneous IND and MAA submissions with overlapping deadlines. I prioritized by assessing regulatory impact and risk, created detailed project plans, and communicated clearly with stakeholders. I delegated tasks where possible and used tracking tools to monitor progress, ensuring all deadlines were met.

What experience do you have with electronic document management systems (EDMS)?

I have extensive experience with Veeva Vault, Documentum, and SharePoint. I can manage document workflows, version control, and approvals. I also train team members on best practices for document authoring and submission readiness.

How do you stay updated on changing regulatory guidelines for electronic submissions?

I regularly attend industry webinars, review ICH guidelines, and follow updates from health authorities. I also participate in professional groups like DIA and RAPS. This helps me anticipate changes and implement them proactively in submission processes.

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The role

Genmab is seeking a motivated individual to join a team committed to delivering quality submissions. A Senior Manager is responsible for activities related to regulatory publishing and submission management support to FDA, EMA, MHRA, SwissMedic and more. Seeks to contribute into innovation process while supporting GRA strategy and deliverables. Supports activities to implement new technology solutions in support of regulatory publishing business process.

Responsibilities

Responsible for the creation, assembly, and publishing of both major and routine global electronic submissions (eCTD and NeeS), including MAA, BLAs and INDs for Original Applications, DSURs, Supplements, and more.
Serve as the global submissions’ expert, guiding teams on e-submission standards (eCTD, NeeS, etc.) and lifecycle management, while clearly communicating regional regulatory differences.
Perform QC and technical validation of electronic submissions to ensure compliance with internal standards and external criteria before delivery to the Regulatory Users for internal review/approval.
Adherence to required submission timelines, health authority publishing specifications, and internal working practices.
Liaise with functional source areas (clinical, nonclinical, regulatory) to ensure documents are compliant with authoring style guide. Work with regulatory document authors to achieve resolution and ensure that documents comply with regulatory and company guidance/template specifications.
Maintain working knowledge of the regulations and processes that govern the content and maintenance of controlled documents required by the Health Authorities and ICH.
Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.

Requirements

BA/BS degree or equivalent, at least 8 years pharmaceutical industry experience, and prior Regulatory Operations experience required.
Knowledge of IND, BLA, MAA,regarding CTD requirements and guidelines, for both eCTD and NeeS.
Knowledge of industry trends regarding electronic submissions.
Technical knowledge of electronic publishing systems and software.
Proficiency with MS-Office Suite and Adobe Acrobat application.
Knowledge of health authority procedures/guidance’s regarding electronic submissions.
Knowledge of Electronic Document Management Systems.
Ability to balance multiple tasks to meet priorities and timelines.
Self-starter with superior time management skills, and ability to work independently or in teams.
Strong attention to detail.
Strong communication skills – both oral and written
Nice to have submission management skills.

About You

You are genuinely passionate about our purpose
You bring precision and excellence to all that you do
You believe in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
You take pride in enabling the best work of others on the team
You can grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

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